Status:
UNKNOWN
The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease
Lead Sponsor:
Corbridge Group Philippines, Inc.
Collaborating Sponsors:
Alfasigma S.p.A.
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus
- positive 2 of 3 ACR \> 300 mg/g or 24h urine protein or albumin collection \> 300 mg/d in the absence of urinary tract infection
- serum creatinine 1.3 - 3 mg/dl in women and 1.5 - 3 mg/dl in men
Exclusion
- age of onset of DM \\\< 18 years
- \+ renal disease like non-DM renal disease
- \+ CV diseases such as UA, MI, CABG
- \+ CVA or TIA within last 6 months
- untreated UTI
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
1508 Patients enrolled
Trial Details
Trial ID
NCT01000545
Start Date
November 1 2009
End Date
December 1 2012
Last Update
October 30 2009
Active Locations (7)
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1
Mary Mediatrix Medical Center
Lipa City, Batangas, Philippines
2
Rizal Private Clinics
Metro Manila, Rizal, Philippines
3
Holy Child Hospital
Dumaguete, Philippines
4
Victoriano R. Potenciano Medical Center
Mandaluyong, Philippines